FDA.reportPublic FDA data

Himplant Pre-Formed Penile Silicone Block

Primary DI
B097IMD001L1
Brand
Himplant Pre-Formed Penile Silicone Block
Company
INTERNATIONAL MEDICAL DEVICES, INC.
Model
Large - Extra Soft
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MIBElastomer, Silicone Block

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MIBElastomer, Silicone BlockEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B097IMD001L1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Silicone-block tissue reconstructive materialA non-sterile, solid chunk of silicone elastomer typically modified to suit the patient anatomy and implanted, after sterilization, for tissue reconstruction during a surgical procedure. The device is typically available as a cube with a rectangular cross-section or with curved surfaces. It may be carved or trimmed into different sizes and shapes for various reconstructive or cosmetic plastic surgery procedures that involve soft-tissue or bone augmentation, or the formation of prosthetic implants (e.g., chin or malar). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
310-652-2600info@intlmeddevices.com
310-652-2600reports@himplant.com

Regulatory Flags#

DUNS number
080156251
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B097IMD001XL1Himplant Pre-Formed Penile Silicone BlockExtra Large - Extra Soft2016-09-23
B097IMD001XXL1Himplant Pre-Formed Penile Silicone BlockExtra Extra Large - Extra Soft2016-09-23
B097IMD009L1Himplant Pre-Formed Penile Silicone BlockLarge - Semi Soft2023-07-13
B097IMD009LLO1Himplant Pre-Formed Penile Silicone BlockLarge - Extra Long - Semi Soft2023-07-13
B097IMD009XL1Himplant Pre-Formed Penile Silicone BlockExtra Large - Semi Soft2023-07-13
B097IMD009XLO1Himplant Pre-Formed Penile Silicone BlockExtra Large - Extra Long - Semi Soft2023-07-13
B097IMD009XXL1Himplant Pre-Formed Penile Silicone BlockExtra Extra Large - Semi Soft2023-07-13
B097IMD006L1Himplant Pre-Formed Penile Silicone BlockLarge - Soft2016-09-23
B097IMD006LLO1Himplant Pre-Formed Penile Silicone BlockLarge - Extra Long - Soft2019-02-15
B097IMD006XL1Himplant Pre-Formed Penile Silicone BlockExtra Large - Soft2016-09-23
B097IMD006XLO1Himplant Pre-Formed Penile Silicone BlockExtra Large - Extra Long - Soft2019-02-15
B097IMD006XXL1Himplant Pre-Formed Penile Silicone BlockExtra Extra Large - Soft2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M724CCB5SIZ7NS1ContourFlex™ Gluteal Implant Sizer RoundIMPLANTECH ASSOCIATES, INC.MIB2024-05-20
M724CCB11SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB12SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB13SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB14SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB15SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB21SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB22SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB23SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB31SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB32SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB33SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB41SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB42SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB43SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB44SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB45SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB5SIZK1NS1ContourFlex™ Gluteal Implant SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB5SIZNC1NS1ContourFlex™ Gluteal Implant SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB5SIZNC3NS1ContourFlex™ Gluteal Implant SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB7SIZ1NS1ContourFlex™ Calf Implant SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB7SIZ3NS1ContourFlex™ Calf Implant SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB50NS1ContourFlex™ Gluteal ImplantIMPLANTECH ASSOCIATES, INC.MIB2017-07-10
B097IMD001XL1Himplant Pre-Formed Penile Silicone BlockINTERNATIONAL MEDICAL DEVICES, INC.MIB2016-09-23
B097IMD001XXL1Himplant Pre-Formed Penile Silicone BlockINTERNATIONAL MEDICAL DEVICES, INC.MIB2016-09-23
M724CCB45NS1Contoured Carving BlockIMPLANTECH ASSOCIATES, INC.MIB2016-04-22
M72423700071AlliedSil™ SheetingIMPLANTECH ASSOCIATES, INC.MIB2015-09-24
M72423700101AlliedSil™ SheetingIMPLANTECH ASSOCIATES, INC.MIB2015-09-24
M72423700151AlliedSil™ SheetingIMPLANTECH ASSOCIATES, INC.MIB2015-09-24
M72423700201AlliedSil™ SheetingIMPLANTECH ASSOCIATES, INC.MIB2015-09-24